Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety
Recruiting · NCT07045116 · Interventional (participants receive a specific treatment) · Lead sponsor: Randa Omer Ahmed Bashir
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes. Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars. Objectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS). Secondary Outcomes: Physiological markers: heart rate and oxygen saturation via pulse oximetry. Salivary amylase levels (anxiety biomarker) assessed using ELISA. Methodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits. Saliva samples are collected before and after each injection. Double-blind setup: children blinded using sunglasses; statistician also blinded. Same operator administers all injections for consistency. Ethical Considerations Written informed consent and assent obtained. Risks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring. Privacy and data security measures in place. Statistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05. Sample size calculated for adequate power (n = 33 minimum; 40 enrolled). Funding Self-funded. Clinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.
Who can take part
Inclusion criteria
- 6-8-year-old children.
- Medically free (ASA class I).
- Children attending their first dental visit.
- The patient should have at least one vital primary molar with deep carious lesion on each side.
Exclusion criteria
- Patient has any allergy to local anesthesia.
- Patients take any medications that affect the salivary flow.
- Patient taken corticosteroid.
- Children whose parents or legal guardians refuse to sign the informed consent.
Where it is running
1 location listed.
- Faculty of Dentistry, Ain Shams university - Cairo, Egypt